Senior Clinical Supply Operations Manager

Benefits

Additional Information

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? - ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. - Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. - Work with a collaborative team with the ability to work across different areas of the company. - Ability to join a growing company with professional development opportunities. Position Summary The Senior Clinical Supply Operations Manager is responsible for overseeing & supporting all aspects of clinical supply planning and logistics in support of ImmunityBio's clinical programs. This position works collaboratively with Clinical Operations, Quality, CMC Program Management and Regulatory Affairs to gather key study information and utilize available systems to create clinical supply plans and coordinate with internal and external partners to supply the necessary clinical material. The role will work closely with the Clinical Packaging/Labeling supplier to initiate labeling, packaging and distribution orders to ensure the timely supply of clinical trial material to enrolled sites. Essential Functions Participate in cross-functional Clinical Study Teams and document study assumptions e.g. drug product, number of subjects, enrollment, treatment schedule, etc.. Develop, & Implement clinical supply and inventory plans and timelines, including clinical drug supply labeling, packaging, and distribution to the sites Manage the Clinical Labeling/Packaging CMO, including initiating the Order Management process and the day-to-day fulfillment of drug shipment requests to depots and sites Identify and communicate clinical drug supply risks to internal and external stakeholders as appropriate Manage review and approval of clinical supply documentation (i.e. clinical labels, master batch records, label proofs, purchase orders/quotes) in conjunction with IB stakeholders including Regulatory, Clinical Operations and Quality Broad understanding of clinical product stability data in support of approved shelf-life and temperature transport and storage conditions Manage the Clinical Inventory reporting and review process, including broad understanding of interactive response systems to manage inventory including the destruction of obsolete and expired clinical drug product Develop and Implement new strategies that have organizational impact that enhance overall efficiency of the department Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates. Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor's degree in Business, Supply Chain Management, Operations Management, Engineering or relevant discipline required 7+ years of business experience with a demonstrated knowledge of Clinical Supply Chain Management concepts and Best Demonstrated Practices required, experience with Global Clinical supply management preferred 7+ years in the pharmaceutical, biopharmaceutical, or biotechnology field with specific experience in Demand Planning, Supply Planning, and Inventory Management required 3+ years of knowledge of computer based Interactive Response System to manage inventory strongly preferred Knowledge, Skills, & Abilities Must have the ability to work independently and also be an influential team member in a fast-paced, team-oriented, dynamic environment Strong problem-solving skills including analytical and critical thinking abilities as well as business and financial analysis Working knowledge of FDA and EMA regulations, as well as cGMP and ICH guidelines applicable to the development and production of investigational and commercial drug products Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines Proficient in Microsoft Suite (Excel, PowerPoint, Project, Visio, Word) Working Environment / Physical Environment This position works on-site (El Segundo,